WINCO FOODS EFFERVESCENT COLD RELIEF- aspirin, chlorpheniramine maleate, and phenylephrine bitartrate tablet, effervescent

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Aspirin 325 mg (NSAID)*, Chlorpheniramine maleate 2 mg, Phenylephrine Bitartrate 7.8 mg, *Nonsteroidal anti-inflammatory drug
Available from:
WinCo Foods, LLC
INN (International Name):
ASPIRIN
Composition:
ASPIRIN 325 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses temporarily relieves these symptoms of the common cold: ■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache ■ minor aches and pains ■ runny nose ■ sinus congestion and pressure temporarily relieves these symptoms of the common cold ■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache ■ minor aches and pains ■ runny nose ■ sinus congestion and pressure ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ if you are allergic to aspirin ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. ■ stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are ta
Authorization status:
OTC monograph final
Authorization number:
67091-109-20

WINCO FOODS EFFERVESCENT COLD RELIEF- aspirin, chlorpheniramine maleate, and

phenylephrine bitartrate tablet, effervescent

WinCo Foods, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Effervescent Cold Relief Tablets

Active ingredients

Aspirin 325 mg (NSAID)*

Chlorpheniramine maleate 2 mg

Phenylephrine Bitartrate 7.8 mg

*Nonsteroidal anti-inflammatory drug

Purpos e

Us es

temporarily relieves these symptoms of the common cold:

■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache

■ minor aches and pains ■ runny nose

■ sinus congestion and pressure

Us es

temporarily relieves these symptoms of the common cold

■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache

■ minor aches and pains ■ runny nose

■ sinus congestion and pressure

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like

symptoms should not use this product. When using this product, if changes in behavior with nausea and

vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a

rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial

swelling ■ asthma (wheezing) ■ shock

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID),

which may cause severe stomach bleeding. The chance is higher if you ■ are age 60 or older ■ have

had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take

other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time

than directed

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or

followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

■ if you have ever had an allergic reaction to any other pain reliever/fever reducer

■ if you are allergic to aspirin

■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for

depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping

the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or

pharmacist before taking this product.

Ask a doctor before use if

■ stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn

■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a

diuretic. ■ you are taking sedatives or tranquilizers. You have ■ glaucoma ■ diabetes ■ thyroid disease

■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or

chronic bronchitis ■ been placed on a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

■ presently taking a prescription drug ■ taking a prescription drug for anticoagulation (thinning the

blood), diabetes, gout or arthritis

When using this product

do not take more than 8 tablets (adults and children 12 years and over) in a 24-hour period or as directed

by doctor.

■ do not use more than directed ■ you may get drowsy ■ avoid alcoholic drinks

■ excitability may occur, especially in children

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

■ you experience any of the following signs of stomach bleeding

■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better

■ an allergic reaction occurs. Seek medical help right away. ■ pain or nasal congestion gets worse or

lasts more than 7 days

■ fever gets worse or lasts more than 3 days ■ new symptoms occur ■ redness or swelling is present

■ ringing in the ears or a loss of hearing occurs ■ nervousness, dizziness or sleeplessness occurs

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3

months of pregnancy unless definitely directed to do so by a doctor because it may cause

problems in the unborn child or complications during delivery.

Keep out of reach of children.

Keep out of reach of children.

In case of overdose,

get medical help or contact a Poison Control Center right away.

Directions

■ do not use more than directed (see overdose warning)

■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 oz of water every 4-6

hours

■ do not take more than 8 tablets in 24 hours

■ children under 12 years: ask a doctor

Other information

each tablet contains:

sodium 464 mg

■ phenylketonurics: contains phenylalanine 9 mg per tablet

■ store at room temperature (59°-86°F)

Inactive ingredients

acesulfame potassium, aspartame, citric acid, docusate sodium, flavors, mannitol, povidone, sodium

benzoate, sodium bicarbonate

Ques tions ?

Or to report an adverse event call

800-824-1706 Monday - Friday

9am - 4pm MST

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

WINCO FOODS EFFERVESCENT COLD RELIEF

aspirin, chlorpheniramine maleate, and phenylephrine bitartrate tablet, effervescent

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 70 9 1-10 9

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

325 mg

CHLO RPHENIRAMINE MALEATE (UNII: V1Q0 O9 OJ9 Z) (CHLORPHENIRAMINE -

UNII:3U6 IO 19 6 5U)

CHLORPHENIRAMINE

MALEATE

2 mg

PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

BITARTRATE

7.8 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

ASPARTAME (UNII: Z0 H242BBR1)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

DO CUSATE SO DIUM (UNII: F0 5Q2T2JA0 )

MANNITO L (UNII: 3OWL53L36 A)

PO VIDO NE K3 0 (UNII: U725QWY32X)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

Product Characteristics

Color

white

S core

no sco re

S hap e

ROUND

S iz e

25mm

Flavor

LEMON

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 70 9 1-10 9 -20

20 in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 2/20 14

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 7/0 2/20 14

Labeler -

WinCo Foods, LLC (056098817)

WinCo Foods, LLC

Revised: 12/2017

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